Water System Vaildation & Monitoring
Process water is the single most important raw material used in pharmaceutical and medical device manufacturing processes. For the last 30 years, Avista Pharma has been among the most experienced and capable laboratories for United States Pharmacopeia (USP) and European Pharmacopeia (EP) purified water testing. Our experts can also advise you on how to set up your pharmaceutical/medical device water testing programs and system validations to ensure they meet specific regulatory requirements. Avista Pharma’s microbiology and analytical testing labs offer a wide range of methods for water analyses to support your validation and routine monitoring needs.
Purified water requires a specific panel of testing be performed as per USP and EP requirements. Avista Pharma is fully outfitted with state of the art equipment and highly trained experts to perform these tests in a timely and accurate manner ensuring the highest quality results.
Avista Pharma’s purified water testing services include:
- Bioburden testing: used to establish the microbial load in water. Bioburden testing is offered using mHPC, R2A and mENDO agars offering a wider range of options to suit your specific needs.
- Conductivity testing: used to establish the sample’s ability to conduct electricity. This measurement relates to the number of dissolved salts (ions) in the sample, which can indicate a potential processing problem.
- Total Organic Carbon (TOC) testing: used to establish whether the level of carbon present in the sample is below the mandated limit. High TOC levels, which are above the mandated levels, are a reliable indicator of sample contamination.
- Heavy Metals and Nitrates testing: if your water also needs to meet EP requirements, Avista is fully equipped to perform Heavy Metals and Nitrates testing. These analyses are used to establish the level of metallic impurities and nitrates in the sample, both of which can lead to significant water quality problems.
If your water is being used for injection or internal applications, USP and EP requires that testing for endotoxins be added to the purified water testing panel. Endotoxin testing is designed to detect specific toxins (lipopolysaccharide) that are found as a structural component of the cell wall of Gram negative organisms. If these toxins are released from the cells, they can elicit a pyrogenic (fever) response in the patient. Avista Pharma is fully capable and experienced in performing endotoxin testing using various methodologies, including gel clot, chromogenic and turbidimetric methods.